Highest Weight Loss and Abdominal Adiposity Loss With Hypocaloric Diet Plan and Auricular Acupuncture

The implications of obesity, especially visceral fat, in health are well known. It would be desirable to control obesity by safe and effective treatment modalities. Aim: To assess the effectiveness of Auricular Acupuncture (AA) on body weight loss in a Portuguese sample.

Study Overview

• Status: Completed
• Conditions: Weight Loss; Abdominal Obesity
• Intervention / Treatment: Dietary supplement: Hypocaloric diet plan; Other: Acupressure; Other: Auricular Acupuncture

Detailed Description

Methods: After a pre-study, a prospective experimental randomized, controlled and single-blinded study was conducted. The sample included 31 adult women with ages ranging from 20 to 51 years old. The groups had a frequency of physical activity ≥ 2 and ≤ 4 times per week. Individuals with BMI ≤ 24.9 Kg/m2 and pregnant women excluded from the study. All participants were then randomized into one of three groups: group 1 was treated with Vaccaria seeds plus diet therapy, group 2 with ASP needles plus diet therapy and finally, group 3 received only diet therapy. A licensed nutritionist prescribed the hypocaloric diet plan. Baseline evaluation included anthropometric measures collected according to standardized procedures. They received two treatments per week for a total of 6 weeks. After one month of follow-up, all the anthropometric measures were reevaluated. Main Parameters: Weight/body composition by bioelectrical impedance analysis. Secondary parameters: Waist to height ratio (WHtR), weight and Body Mass Index (BMI).

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adults
• Unfamiliar to acupuncture

Exclusion Criteria:

• Psychotropic medication
• Psychiatric or thyroid disorders
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
SHAM_COMPARATOR: Vaccaria seeds plus diet therapy; Vaccaria seeds at the exterior side of the ear area, standard points were selected according to clinical experience in traditional Chinese medicine: Shenmen (TF4), Stomach (CO4), Hunger, Mouth (CO1), Point Zero HX1) and Sanjiao (CO17). Mustard seeds (Vaccaria ear seeds, Beijing Zhongyan Taihe Medicine, Beijing, China) were used, plus diet therapy prescribed by a licensed nutritionist.	Dietary supplement: Hypocaloric diet plan; The hypocaloric diet is one in which there is a reduction of daily calories or foods with high caloric density usually in order to aid weight loss.; Other: Acupressure; Auriculotherapy is a technique derived from traditional acupuncture developed into a distinct treatment system of its own. It is based on either, the introduction of needles (auricular acupuncture), or pressure with Vaccaria seeds (acupressure). Those forms of auriculotherapy are applied on a set of anatomical maps at a specific point in the auricular region.; Other Names: Auriculotherapy
ACTIVE_COMPARATOR: ASP needles plus diet therapy; ASP needles on the outside of the ear standard points were selected according to clinical experience in traditional Chinese medicine: ASP gold needles, strengthening the centre with point 0 (the umbilicus) in the dominant ear, Porta Fortunae in the non-dominant ear, Barbiturate in the non-dominant ear, Psychosomatique key point in the dominant ear and the point Aggression, plus diet therapy prescribed by a licensed nutritionist.	Dietary supplement: Hypocaloric diet plan; The hypocaloric diet is one in which there is a reduction of daily calories or foods with high caloric density usually in order to aid weight loss.; Other: Auricular Acupuncture; Auriculotherapy is a technique derived from traditional acupuncture developed into a distinct treatment system of its own. It is based on either, the introduction of needles (auricular acupuncture), or pressure with Vaccaria seeds (acupressure). Those forms of auriculotherapy are applied on a set of anatomical maps at a specific point in the auricular region.; Other Names: Auriculotherapy
NO_INTERVENTION: only diet therapy; only diet therapy prescribed by a licensed nutritionist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight (kg)	TANITA® bio-impedance scale (model 762)	1 month
Waist Perimeter (cm)	tape measure from SECA® (model 203)	1 month
height (cm)	SECA® stadiometer (model 208)	1 month
body fat (%)	TANITA® bio-impedance scale (model 762)	1 month
Body mass index (kg/m2)	Body mass index is defined as the body mass divided by the square of the body height.	1 month
Waist-to-height ratio (cm2)	The WHTR was obtained by dividing the waist circumference (cm) by height (cm).	1 month

Collaborators and Investigators

• Sponsor: Andreia Vieira

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2015
• Primary Completion (ACTUAL): September 1, 2015
• Study Completion (ACTUAL): December 15, 2015

Study Registration Dates

• First Submitted: March 31, 2021
• First Submitted That Met QC Criteria: April 2, 2021
• First Posted (ACTUAL): April 8, 2021

Study Record Updates

• Last Update Posted (ACTUAL): April 8, 2021
• Last Update Submitted That Met QC Criteria: April 2, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight Changes; Obesity; Weight Loss; Body Weight; Obesity, Abdominal
• Other Study ID Numbers: uportoweightloss (REGISTRY: uportoweightloss)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No